FDA Grants 510(k) Clearance to Surefire for Direct-to-Tumor Drug Delivery Device
The FDA has granted 510(k) clearance to Surefire Medical Inc. for its Surefire Precision, an infusion system with an expandable tip that increases drug delivery directly to a tumor while protecting healthy tissue.
A study published in the Journal of Vascular and Interventional Radiology found that compared to conventional end-hole catheters, the device enabled increased uptake of particles by an average of 68 percent, and up to 90 percent in treating primary liver cancer.
The company says the device provides physicians greater selectivity in accessing patients’ smaller peripheral blood vessels.
Westminster, Colo.-based Surefire develops infusion systems for the interventional radiology and interventional oncology markets. — Michael Cipriano